Smoking Cessation Clinical Trial
Official title:
The Effect of Very Brief Smoking Reduction Intervention in Smokers Who Having no Intention to Quit: Study Protocol for a Randomized Controlled Trial
Verified date | February 2015 |
Source | Chinese PLA General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
A two-arm randomized controlled trial for smokers who are not intent to quit smoking will be proposed in outpatient department clinics of People's Liberation Army General Hospital in Beijing, China. Smoking reduction intervention arm (SRI) consisting of a very brief face-to-face individual smoking reduction intervention lasted about one minute, and five follow-up interventions lasted for about minute each. Control arm (EDA) consisting of a very brief face-to-face individual exercise and dietetic advices lasted for the same intervention time as SRI, and also five follow-up interventions lasted for one minute each with different intervention contents.
Status | Not yet recruiting |
Enrollment | 500 |
Est. completion date | June 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Aged =18 years old; 2. Smoked more than 10 cigarettes per day in the past month. 3. Have no intent to smoking cessation now. 4. Agreed to participate in the follow-up, offer telephone number and signed an informed consent form. Exclusion Criteria: 1. Smoked less than 10 cigarettes per day in the past month. 2. Had some diseases that let the physician think that it would be unethical not to advise him to quit smoking as soon as possible. 3. Cognitively impaired (such as those with deafness or who could not understand and complete the questionnaire reliably). 4. Pregnant females. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | self-reported 7-day point prevalence quit rate | at 12 months follow-up | No | |
Primary | prolonged abstinence quit rate | at 12 months follow-up | No | |
Secondary | smoking reduction rates | number of cigarettes smoked per day reduced at least 50% | baseline and at 12 months follow-up | No |
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